Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Synthes GmbH — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

146 daysmedian FDA review time
345 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH2026-03-10810
K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH2026-03-09590
K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2Synthes GmbH2026-03-02750
K243715Synthes Patient Specific ImplantsSynthes GmbH2025-11-123450
K241927Synthes Graphic Case & Tray SystemSynthes GmbH2025-03-282700
K233994VOLT™ Proximal Humerus 3.5 Plating SystemSynthes GmbH2024-07-262210
K233967DePuy Synthes MatrixSTERNUM Fixation SystemSynthes GmbH2024-05-091460

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda